37  Data Quality Framework

37.1 What is Data Quality?

High-quality clinical data is: - Accurate - Complete - Timely - Consistent - Traceable to source

37.2 CRA Data Quality Domains

• Data entry (EDC)
• Source documentation
• Query management
• Protocol adherence
• Safety reporting

37.3 Inspection Reality

Inspectors assess not just errors, but whether the data quality system itself is effective.